Exhibit 091

Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial (Study 329)

Exhibit 091 · Randomized trial report

Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial (Study 329)

generally well tolerated and effective for major depression in adolescents

Reported an eight-week, randomized, double-blind comparison of paroxetine, imipramine and placebo in 275 adolescents with major depression. The favorable results emphasized particular symptom measures. PubMed now links the article to a 2025 expression of concern.

Source: Keller et al., Journal of the American Academy of Child and Adolescent Psychiatry
Date: 2001
Quoted from: Abstract, conclusions
Grade: Peer-reviewed
Document: https://pubmed.ncbi.nlm.nih.gov/11437014/
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Cited by

Finding MED-4.2: Peer-reviewed A 2001 article reported paroxetine effective and well tolerated in depressed adolescents. A 2015 reanalysis of the same trial's records found no advantage over placebo on the prespecified outcomes and counted 11 paroxetine patients with suicidal or self-injurious behavior where the article had counted five.